Dennis C. Pfannenschmidt, United States Attorney for the Middle District of Pennsylvania, announced that Curtis L. Hess, age 49, of York, Pennsylvania, was sentenced yesterday to a 16-month term of imprisonment by United States District Court Senior Judge Edwin M. Kosik for introducing misbranded drugs into interstate commerce with the intent to defraud and mislead. Judge Kosik further ordered him to pay a $18,000 fine. Hess also forfeited $76,291.80.

According to U.S. Attorney Pfannenschmidt, beginning in January 2005 and continuing until April 2006, Hess--through his company, Hess Rx Distribution, L.L.C.--smuggled prescription drugs from Canada into the United States. The drugs, although having similar names and active ingredients to drugs available in the United States, were not FDA-approved for marketing and distribution in the United States. Hess distributed these drugs to pharmacies throughout the country. Patients who received these drugs from pharmacies were unaware that they had been smuggled into the United States. Before Hess' operation was shut down by FDA agents, he had distributed approximately $475,000 worth of unapproved prescription pharmaceuticals.

Hess was charged in September 2009 and later pleaded guilty.

"This investigation, prosecution and sentencing demonstrates that the FDA takes seriously the threat posed by those individuals who operate outside the secure pharmaceutical supply chain by illegally importing and distributing non-FDA approved products to unsuspecting US consumers," said Thomas P. Doyle, Special Agent in Charge, FDA's Office of Criminal Investigations, Metro Washington Field Office. "Those who engage in such criminal conduct will be held liable."

This case was investigated by the Food and Drug Administration's Office of Criminal Investigations and prosecuted by Assistant United States Attorney Joseph J. Terz.

Source
U.S Food and Drug Administration